Annex XV dossier PROPOSAL FOR ... - ECHA - Europa

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ANNEX XV – IDENTIFICATION OF PMDA AS SVHC
PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A
CATEGORY 1A OR 1B CMR, PBT, VPVB OR A SUBSTANCE OF
AN EQUIVALENT LEVEL OF CONCERN
Substance Name(s): Formaldehyde, oligomeric reaction products with aniline
EC Number: 500-036-1
CAS number: 25214-70-4
• The substance is proposed to be identified as substance meeting the criteria of Article 57 (a) of
Regulation (EC) 1907/2006 (REACH) owing to its classification as carcinogen 1 B 1 which
corresponds to classification as carcinogen category 2 2 ..
Summary of how the substance(s) meet(s) the CMR (Cat 1A or 1B) criteria
The structurally related substance 4,4’-diaminodiphenylmethane is listed by index number 612-051-
00-1 of Regulation (EC) No 1272/2008 and classified in Annex VI, part 3, Table 3.1 (the list of
harmonised classification and labelling of hazardous substances) as carcinogenic: Carc. 1B (H 350:
“May cause cancer.”). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of
harmonised and classification and labelling of hazardous substances from Annex I to Directive
67/548/EEC) of Regulation (EC) No 1272/2008 is Carc. Cat. 2; R45 (“May cause cancer.”).
4,4’-diaminodiphenylmethane is a major constituent of the UVCB substance formaldehyde,
oligomeric reaction products with aniline (CAS-No. 25214-70-4) and therefore the classification
for 4,4’-diaminodiphenylmethane applies also for this UVCB substance. The classification of
,4’-diaminodiphenylmethane in Regulation (EC) No 1272/2008 shows that also the UVCB
substance formaldehyde, oligomeric reaction products with aniline meets the criteria for
classification as carcinogenic in accordance with Article 57 (a) of REACH.
Registration dossiers submitted for the substance? Yes
1 Classification in accordance with Regulation (EC) No 1272/2008 Annex VI, part 3, Table 3.1 List of harmonised classification and
labelling of hazardous substances.
2 Classification in accordance with Regulation (EC) No 1272/2008, Annex VI, part 3, Table 3.2 List of harmonised classification and
labelling of hazardous substances (from Annex I to Council Directive 67/548/EEC).